TY - JOUR
T1 - Acting on black box warnings requires a GRADE evidence table and an implementation guide
T2 - The case of teriparatide
AU - Elraiyah, Tarig
AU - Gionfriddo, Michael R.
AU - Murad, Mohammad Hassan
N1 - Publisher Copyright:
© 2015 Elsevier Inc. All rights reserved.
PY - 2015/6/1
Y1 - 2015/6/1
N2 - Objectives To assess how well do the black box warnings present and communicate evidence in a way that is consistent with evidence-based patient-centered practice, through evaluating the boxed warning on teriparatide-induced osteosarcoma. Study Design and Setting We critically appraised teriparatide black box warning for osteosarcoma by reviewing human and animal studies that were used as basis for the warning. We also evaluated the quality of the evidence using the Grading of Recommendations Assessment, Development and Evaluation framework. Results We found that this warning was based on very low-quality evidence that was derived primarily from animal studies. The quality of evidence was rated down because of high risk of bias in addition to inconsistency, indirectness, and imprecision of the estimates. The warning does not provide sufficient guidance for practice like an implementation tool or an evidence profile to clarify the limitations of the evidence. Conclusion Black box warning for teriparatide-associated osteosarcoma does not explicitly present the quality of evidence, and therefore, it could be of limited use in evidence-based practice. We propose that black box warnings should include an evidence profile and an implementation guide to be more useful in evidence-based patient-centered practice.
AB - Objectives To assess how well do the black box warnings present and communicate evidence in a way that is consistent with evidence-based patient-centered practice, through evaluating the boxed warning on teriparatide-induced osteosarcoma. Study Design and Setting We critically appraised teriparatide black box warning for osteosarcoma by reviewing human and animal studies that were used as basis for the warning. We also evaluated the quality of the evidence using the Grading of Recommendations Assessment, Development and Evaluation framework. Results We found that this warning was based on very low-quality evidence that was derived primarily from animal studies. The quality of evidence was rated down because of high risk of bias in addition to inconsistency, indirectness, and imprecision of the estimates. The warning does not provide sufficient guidance for practice like an implementation tool or an evidence profile to clarify the limitations of the evidence. Conclusion Black box warning for teriparatide-associated osteosarcoma does not explicitly present the quality of evidence, and therefore, it could be of limited use in evidence-based practice. We propose that black box warnings should include an evidence profile and an implementation guide to be more useful in evidence-based patient-centered practice.
KW - Black box warning
KW - Evidence-based practice
KW - GRADE
KW - Implementation
KW - Osteosarcoma
KW - Quality of evidence
KW - Teriparatide
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U2 - 10.1016/j.jclinepi.2015.01.025
DO - 10.1016/j.jclinepi.2015.01.025
M3 - Article
C2 - 25766055
AN - SCOPUS:84928926493
SN - 0895-4356
VL - 68
SP - 698
EP - 702
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
IS - 6
ER -